Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 235-558-6 | CAS number: 12286-66-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
Four studies were performed to evaluate acute oral and dermal toxicity of the test substance and a structural analogue to the rat (according or similar to OECD 401, 402). Neither the test substance nor the analogue induced any mortalities, abnormalities or clinical signs when applied oral or dermal. The LD50 for oral and dermal toxicity is considered to be > 10.000 mg/kg bw and > 2000 mg/kg bw, respectively.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- similarities to OECD guideline 401
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CFE (RAC, SPF) strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 126 - 139 g
- Fasting period before study: /
- Housing: groups of 5 in macrolon cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 14h - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % in tap water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25%
- total volume: 20 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10.000 mg/kg bw - Doses:
- 5000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5000 mg/kg bw : 5 per sex and dose
10000 mg7kg bw : 3 males and 2 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 8d
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no - Statistics:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Mortality:
- no martalities
- Clinical signs:
- no clinical symptoms
- Body weight:
- pre-test: 131 g and 129 g
day 8: 18 3g and 184 g - Other findings:
- yellow stained feces
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 was established to be > 10000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding farm VELAZ S.f.O., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Weight at study initiation: males 258 g, females 189 g
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10
- Type of wrap if used: semiocclusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution):
- Constant volume or concentration used: unchanged substance, constant dose level, volume individual
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing before application, 8th and 15th day of study, observation daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no
- Clinical signs:
- no
- Body weight:
- no abnormalities
- Gross pathology:
- no abnormalities
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of study, the value of LD50 (dermal) of the test substance is higher than 2000 mg/kg bw for rats of both sexes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Read across justification
Acute toxicity effects were assessed at the test item itself and, additionally, at structural analogues. All substances are calcium-salts and share high similarity in structure. Moreover, the substances are minimal soluble in water. Therefore, it is acceptable to derive additional information on acute toxicity from experimental data of the analogue substances.
Procedure and observations
To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article were administrated to groups of male and female rats by oral gavage (Ciba 1972a). Following dosing, the animals were observed for 8d. There were no deaths as a result of treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.
In the course of a second study according OECD guideline 401, a single dose of 15.85 g/kg bw of the test item dissolved in olive oil was administrated orally to rats (Synthesia 1993). All animals survived until scheduled necropsy. Any symptoms or clinical signs did not occur. However, analytical data and purity of the test material were not confirmed by the provider. Thus, this study is regarded as not reliable.
Read across to CAS 5280 -70 -6
A structural analogue (Ba-salt) was also tested for acute oral toxicity. In a limit test similar to OECD guideline 401 a single dose of 5000 mg/kg bw of the test material dissolved in carboxymethyl-cellulose was administrated to rats by gavage (Ciba 1980). The post observation period was 14d and animals were daily checked for clinical signs and mortalities. All animals survived until scheduled necropsy, body weights were uneffected by the substance and signs of toxicity were also not observed. Pathology was without any findings.
Dermal toxicity of the test item was evaluated on a group of 6 male rats which were treated with the test article at 5000 mg/kg for 24h by dermal application (Synthesia 1993). The substance was suspended in water and administrated onto greased (ethanol:acetone 1:1) skin. Animals were examined for clinical signs and viability 0.5, 3, 12, 24 and 72h after treatment. All animals were necropsied and examined macroscopically. No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. However, analytical data and purity of the test material were not confirmed by the provider. Thus, this study is regarded as not reliable.
Read across to CAS 12286-65-6
The substance was tested for acute dermal toxicity using Wistar rats. Two groups of animals (5 males and 5 females) received a single dose of 2000 mg/kg bw. The test material was applied onto shaved dorsal skin for 24 hours. The test animals were observed 14 days after exposure of the test substance, afterwards they were sacrificed, and the necropsy for macroscopic examination of the organs was performed. The test item did not cause mortalities. Clinical signs or macroscopic changes were not observed.
Discussion
Oral application of the test substance and a structural analogue did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Also dermal application did not induce any symptoms or mortalities. Thus, the substance is not considered to be toxic after single oral or dermal application.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2